On March 29, 2018, KEI asked the NIH to investigate the failure of the University of Pennsylvania and Daniel J. Rader to report NIH funding relating to 6 patents in the FDA Orange Book for the drug Juxtapid (INN lomitapide).… Continue Reading
1994. The 1994 NIH Report on CRADAs and the Reasonable Pricing Clause 1994. September 8. James Love. Pricing of Drugs Developed with Public Funds. Comments Presented to the Second NIH CRADA Forum. 1995. April 11. NIH Notice Rescinding the Reasonable… Continue Reading
In the attached letter dated March 14, 2018 to Secretary of the Department of Health and Human Services (DHHS) Alex Azar, KEI is asking for an investigation into a failure to report NIH funding on US patent 7,964,580. This is… Continue Reading
KEI Briefing Note 2018:1. Bayh-Dole Obligations to Disclose Federal Funding Government oversight of under-reporting U.S. federal rights in patents. 1994. June 15, 1994, Inspector General Report to HHS on the under-reporting of federal funding of inventions at the Scripps Research… Continue Reading
Bayh-Dole cases involving royalty free or march-in rights 1997 Cellpro case This was a strong case involving two competing medical devices, both invented on NIH grants, and a bad ending. The NIH rejection of the Cellpro march-in request led to… Continue Reading
KEI has appealed the NIH/NCI decision to proceed with the proposed exclusive license of anti-CD30 CAR T to Gilead, following an email of January 25, 2018 from Dr. David Lambertson of NCI rejecting all of KEI’s substantive suggestions and objections. KEI… Continue Reading
Public and Private Sector Funded Research for Fabry’s Disease KEI Research Note 2010:2 23 July 2010 Introduction Fabry’s disease is a rare genetic multisystemic disorder associated with progressive lipid accumulation and cell damage, leading to a variety of aliments, including… Continue Reading
On February 14, the NIH was asked what the budget was for the Phase 1 clinical trial of the anti-CD30 CAR T technology that is the subject of a proposed exclusive patent license to Kite/Gilead. The clinicaltrials.gov identifier for the… Continue Reading